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The purpose of this post approval study is to further characterize the safety profile of the ProGEL™ Pleural Air Leak Sealant in commercial use, with specific reference to long-term safety over 90 days of follow-up.
Patients having open thoracotomy involving lung resection surgery will be considered for the study. Subjects will be examined for adverse events and complications from either the treatment or the procedure. Follow-up visits are required at 30 days and 90 days after the surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Other | No treatment. |
|
| ProGEL Pleural Air Leak Sealant with standard surgical closure | Experimental | Standard surgical closure (suturing or stapling of visible air leaks incurred during resection of lung parenchyma) plus Progel Pleural Air Leak Sealant. |
|
| ProGEL Pleural Air Leak Sealant without standard surgical closure | Experimental | Progel Pleural Air Leak Sealant without standard surgical closure (without suturing or stapling of visible air leaks incurred during resection of lung parenchyma). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control | Other | Standard surgical techniques including staples and sutures. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoints |
| 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert J. Cerfolio, MD | University of Alabama in Birmingham | Principal Investigator |
| Daniel L. Miller, MD | WellStar Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Vincent Birmingham & St. Vincent East | Birmingham | Alabama | 35243 | United States | ||
| University of Alabama in Birmingham |
The original Protocol was designed to study ProGel (any usage) versus no ProGel. After the study was completed, the FDA requested that the ProGel group be broken out by patients with standard closure, and without.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | No treatment. Control: Standard surgical techniques including staples and sutures. |
| FG001 | ProGEL Pleural Air Leak Sealant | Standard surgical technique plus Progel Pleural Air Leak Sealant. ProGEL Pleural Air Leak Sealant: ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ProGEL Pleural Air Leak Sealant with standard surgical closure |
| Device |
ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG). Standard closure means, for example, suturing or stapling of visible air leaks incurred during resection of lung parenchyma. |
|
| ProGEL Pleural Air Leak Sealant without standard surgical closure | Device | ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG). Standard closure means, for example, suturing or stapling of visible air leaks incurred during resection of lung parenchyma. |
|
| Birmingham |
| Alabama |
| 35894 |
| United States |
| Jacksonville Center for Research | Jacksonville | Florida | 32207 | United States |
| Moffit Cancer Center | Tampa | Florida | 33612 | United States |
| WellStar Research Institute | Atlanta | Georgia | 30060 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| St. Vincent Hospital and Health Care Center | Indianapolis | Indiana | 46290 | United States |
| Greater Baltimore Medical Center | Baltimore | Maryland | 21204 | United States |
| Mass General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham Womens' Hospital | Boston | Massachusetts | 02115 | United States |
| Beth Israel Deconess Medical Center | Boston | Massachusetts | 02215 | United States |
| UMass Memorial Medical | Worcester | Massachusetts | 01605 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Lancaster General Hospital | Lancaster | Pennsylvania | 17602 | United States |
| Virginia Commonwealth University Medical Center | Richmond | Virginia | 23298 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98104 | United States |
| Dean Foundation for Health, Research and Education, Inc. | Madison | Wisconsin | 53715 | United States |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | No treatment. Control: Standard surgical techniques including staples and sutures. |
| BG001 | ProGEL Pleural Air Leak Sealant With Standard Surgical Closure | ProGEL Pleural Air Leak Sealant: ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG). Standard closure, for example, by suturing or stapling, of visible air leaks incurred during resection of lung parenchyma. |
| BG002 | ProGEL Pleural Air Leak Sealant Without Standard Surgical Closure | ProGEL Pleural Air Leak Sealant: ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG). Without standard closure, for example, suturing or stapling, of visible air leaks incurred during resection of lung parenchyma. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Height | Mean | Standard Deviation | centimeters |
| |||||||||||||||
| Weight | Mean | Standard Deviation | kilograms |
| |||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety Endpoints |
| Units analyzed represents the number of adverse events that occurred among all study participants in each arm. Also, the original Protocol was designed to study ProGel (any usage) versus no ProGel. After the study was completed, the FDA requested that the ProGel group be broken out by patients with standard closure, and without. | Posted | Count of Units | Events | 90 days | Events | Events |
|
|
|
90 days post-index procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | No treatment. Control: Standard surgical techniques including staples and sutures. | 6 | 168 | 40 | 168 | 39 | 168 |
| EG001 | ProGEL Pleural Air Leak Sealant With Standard Surgical Closure | ProGEL Pleural Air Leak Sealant: ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG). Standard surgical closure (standard closure with, sutures or staples, for example) plus Progel Pleural Air Leak Sealant. | 5 | 169 | 37 | 169 | 52 | 169 |
| EG002 | ProGEL Pleural Air Leak Sealant Without Standard Surgical Closure | ProGEL Pleural Air Leak Sealant: ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG). Progel Pleural Air Leak Sealant without standard surgical closure (standard closure with, sutures or staples, for example). | 2 | 107 | 27 | 107 | 33 | 107 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Persistent air leak | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Late onset air leak | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Residual Plueral Space | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Renal abnormalities | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Myocardial Infarction | Cardiac disorders | Non-systematic Assessment |
| ||
| Atrial Arrhythmia | Cardiac disorders | Non-systematic Assessment |
| ||
| Ventricular Arrythmia | Cardiac disorders | Non-systematic Assessment |
| ||
| Cardiac arrest, resuscitated | Cardiac disorders | Non-systematic Assessment |
| ||
| Death, All Causes | General disorders | Non-systematic Assessment |
| ||
| Hospital Readmission | General disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Persistent Air Leak | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Atrial Arrhythmia | Cardiac disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dawn Heimer, PhD | Davol, Inc. | +1-401-825-8681 | Dawn.Heimer@CRBard.com |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Black |
|
| Asian |
|
| Hispanic |
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| Other |
|
| Late onset air leak |
|
| Residual pleural space |
|
| Acute respiratory distress syndrome |
|
| Renal abnormalities |
|
| Myocardial Infarction |
|
| Atrial Arrythmia |
|
| Ventricular Arrythmia |
|
| Cardiac Arrest, Resuscitated |
|
| Death, all causes |
|
| Hospital readmission |
|